Zdrowie i gospodarka · 17.04.2019
Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities; Public Workshop
The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities." Convened by the Duke-Robert J. Margolis Center for Health Policy at Duke University in partnership with the Critical Path Institute and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss challenges and opportunities to advance the development and application of analysis data standards in drug development and regulatory review. This public workshop is being organized to fulfill FDA's commitment in section (I)(J)(5)(c) of the Prescription Drug User Fee Reauthorization Performance Goals and Procedures Fiscal Years 2018 through 2022 (PDUFA VI goals letter; available at https://www.fda.gov/downloads/forindustry/userfees/ prescriptiondruguserfee/ucm511438.pdf) to convene a public workshop to advance the development and application of analysis data standards. FDA will use the information from this public workshop to inform ongoing and future analysis data standards initiatives and strategic planning to i